Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2002-01-31
2016-11-30
Brief Summary
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In this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.
Detailed Description
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All the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Chemotherapy for Good responder
Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma
Doxorubicin+cisplatin+ifosfamide
Chemotherapy for Good responder high grade osteosarcoma
Chemotherapy for Poor responder
Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma
Doxorubicin+cisplatin+ifosfamide+methotrexate
Chemotherapy for Poor responder high grade osteosarcoma
Interventions
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Doxorubicin+cisplatin+ifosfamide
Chemotherapy for Good responder high grade osteosarcoma
Doxorubicin+cisplatin+ifosfamide+methotrexate
Chemotherapy for Poor responder high grade osteosarcoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma.
3. Age: 41 - 65
4. Normal bone marrow, hepatic, cardiac and renal function
5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide
6. Written informed consent
Exclusion Criteria
2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol
3. Previous chemotherapy treatment for the current tumor
4. White blood count \< 3.0 x 109/L, and platelets \< 100 x 109/L
5. Creatinine clearance \< 70 ml/min
6. Left ventricular ejection fraction \< 55% or fractional shortening rate of the left ventricle \<28%
7. Serum transaminases and bilirubin \> 2 times the normal values
8. ECOG performance status \> 2
9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and Ewing's family tumors.
41 Years
65 Years
ALL
No
Sponsors
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Scandinavian Sarcoma Group
OTHER
Cooperative Osteosarcoma Study Group
UNKNOWN
Italian Sarcoma Group
NETWORK
Responsible Party
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Principal Investigators
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Stefano Ferrari, MD
Role: PRINCIPAL_INVESTIGATOR
Italian Sarcoma Group
Locations
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Cooperative Osteosarcoma Study Group
Stuttgart, , Germany
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Bologna, Italy
Scandinavian Sarcoma Group
Lund, , Sweden
Countries
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Related Links
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Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 years
Other Identifiers
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EURO-B.O.S.S
Identifier Type: -
Identifier Source: org_study_id